Reviewed by Peptide Treatments Medical Advisory Board (Medical Advisory Board)
Orforglipron: Regulatory Status
Current legal and regulatory status for Orforglipron across jurisdictions. This page reflects the most recent verified information and is updated as regulatory actions occur.
Back to Orforglipron overviewUnited States
⚗
Research Only
Compounding status: not applicable. WADA: not specifically listed. Phase 3 ACHIEVE program ongoing globally; first non-peptide oral GLP-1RA in late-stage development
Last verified:
What This Means
Reclassification is not the same as FDA approval.
Even if Orforglipron moves to Category 1, it remains an off-label therapeutic that requires physician supervision. Category 1 means it can be compounded under section 503A — it does not confer approved-drug status.